NMPA Grants Priority Review for CARsgen's Satri-cel Treatment
SHANGHAI— CARsgen Therapeutics Holdings Limited (HK Exchange: 2171), a leading innovator in CAR T-cell therapies, announced on May 28, 2025, that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Priority Review to its autologous CAR T-cell product candidate, satricabtagene autoleucel (satri-cel, CT041), for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy.
About Satri-cel
Satri-cel is an innovative CAR T-cell product targeting the protein Claudin18.2. It is designed to treat Claudin18.2-positive solid tumors, primarily focusing on G/GEJA and pancreatic cancer (PC). With several ongoing trials—such as investigator-initiated trials (CT041-CG4006 and NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01 and NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05 and NCT05911217), and an investigator-initiated trial for satri-cel as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010 and NCT06857786)—it has the potential to be the first-in-class globally. Satri-cel was granted Breakthrough Therapy Designation by the CDE of China's NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. The product also received Regenerative Medicine Advanced Therapy designation by the U.S. FDA for advanced G/GEJA with Claudin18.2-positive tumors in January 2022 and Orphan Drug designation from the US FDA for the treatment of G/GEJA in September 2020.
CARsgen Therapeutics Holdings Limited
CARsgen is a biopharmaceutical company specializing in the development of innovative CAR T-cell therapies addressing unmet clinical needs, including hematologic malignancies, solid tumors, and autoimmune diseases. With comprehensive capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production, the company aims to be a global leader in providing cutting-edge cell therapies for patients worldwide and aims to make cancer and other diseases curable.
Forward-looking Statements
The press release contains forward-looking statements that represent the company's current views, projections, and expectations regarding future events as of the date of this press release. These statements are subject to significant risks and uncertainties, and actual events or results may differ materially from those expressed or implied in the forward-looking statements. For more information on these risks, refer to the company's most recent annual report and interim report and other announcements and reports available on its corporate website, www.carsgen.com.
- The upcoming treatments for Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) may include novel medical-conditions targeting therapies and treatments, such as the autologous CAR T-cell product candidate, satricabtagene autoleucel (satri-cel, CT041), which targets the protein Claudin18.2 and is currently being tested in various clinical trials.
- The potential benefits of satri-cel extend not only to gastric and gastroesophageal cancers but also to pancreatic cancer, positioning it as a significant advancement in health-and-wellness for those affected by solid tumors.
- Science continues to evolve, with promising breakthrough therapies like satri-cel, leading companies such as CARsgen Therapeutics Holdings Limited to emerge as key players in transforming the landscape of health-and-wellness, particularly in the field of cancer treatments.
